Methods and compositions for increasing the effectiveness of antiviral agents

Abstract

Compositions and method of the present invention comprise novel formulations for increasing the effectiveness of antiviral agents and for preventing and treating symptoms associated with the common cold and viral infections. The present invention is directed to treating symptoms resulting from viral infections and diseases associated with Picornaviridae, Coronaviridae, Orthomyxoviridae, Paramyxovirinae, Reoviridae, and Adenoviridae. The novel formulations provided herein improve the therapeutic ratio of antiviral agents such as pleconaril.

What is claimed: 
     
         1 . A composition comprising an antiviral therapeutic agent wherein said
 antiviral therapeutic agent comprises pleconaril,   wherein said pleconaril is optimized for therapeutic efficacy,   wherein said composition consists of pleconaril in an inclusion complex,   or wherein the pleconaril is incorporated into micelles,   and wherein the pleconaril particles in the inclusion complex   or in the micelles are in the size range of 1-50, 5-40, 10-35 microns.   
     
     
         2 . The composition of  claim 1 , wherein said pleconaril is optimized for ease of delivery, for dosing, for stability and reduced toxicity. 
     
     
         3 . The composition of  claim 1 , wherein said pleconaril is optimized for site-specific delivery, wherein such sites comprise the nasophaiynx and anterior internal nares. 
     
     
         4 . The composition of  claim 1 , wherein said pleconaril is designed to have a reduction in adverse events and drug-drug interactions. 
     
     
         5 . The composition of  claim 1 , wherein the inclusion complex comprises cyclodextrins, and wherein the micelles are formed within surfactants. 
     
     
         6 . The composition of  claim 1 , wherein the composition comprises a biocompatable, biodegradable and bioadhesive formulation. 
     
     
         7 . The composition of  claim 1 , further comprising pharmaceutically acceptable oils, pharmaceutically acceptable excipients, or hydrofluorocarbons. 
     
     
         8 . The composition of  claim 7 , wherein the composition is suitable for administration from a pressurized metered dose inhaler device. 
     
     
         9 . The composition of  claim 1 , further comprising ester mixtures or mixture of saturated fatty acids. 
     
     
         10 . The composition of  claim 1 , wherein the composition is administered to a subject in need thereof intranasally, orally, parenterally, intravenously, subcutaneously, intramusculary, intraperitoneally, transdermally, extracorporeally, by intracavity administration, transdermally, topically, by topical intranasal administration, by inhalation, or ophthalmically. 
     
     
         11 . The composition of  claim 1 , wherein the composition is suitable for treating viral infections and diseases associated with Picornaviridae, Coronaviridae, Orthomyxoviridae, Paramyxovirinae, Reoviridae, and Adenoviridae. 
     
     
         12 . A method for treating viral infections and diseases associated with Picornaviridae, Coronaviridae, Orthomyxoviridae, Paramyxovirinae, Reoviridae, and Adenoviridae comprising administering a composition comprising an antiviral therapeutic agent, wherein said antiviral therapeutic agent comprises pleconaril,
 wherein said pleconaril is optimized for therapeutic efficacy,   wherein said composition consists of pleconaril in an inclusion complex, or wherein the pleconaril is incorporated into micelles,   and wherein the pleconaril particles in the inclusion complex or in the micelles are in the size range of 1-50, 5-40, 10-35 microns   and wherein administration of the pleconaril reduces symptoms associated with the viral infection.   
     
     
         13 . The method of  claim 12 , wherein the composition is optimized for ease of delivery, for dosing, for stability and reduced toxicity. 
     
     
         14 . The method of  claim 13 , wherein the composition is optimized for site-specific delivery, wherein such sites comprise the nasopharynx and anterior internal nares. 
     
     
         15 . The method of  claim 12 , wherein the symptoms associated with the viral infection comprise rhinorrhea, runny nose, general congestion, nasal congestion, sneezing, fever, sore throat, cough, headache, body ache, muscle aches, muscle weakness, malaise, exhaustion, uncontrollable shivering, chills, otitis media, loss of appetite, pneumonia and bronchiolitis. 
     
     
         16 . The method of  claim 12 , wherein the composition further comprises pharmaceutically acceptable oils, pharmaceutically acceptable excipients, or hydrofluorocarbons. 
     
     
         17 . The method of  claim 12 , wherein the composition is administered to a subject in need thereof intranasally, orally, parenterally, intravenously, subcutaneously, intramusculary, intraperitoneally, transdermally, extracorporeally, by intracavity administration, transdermally, topically, by topical intranasal administration, by inhalation, or ophthalmically. 
     
     
         18 . The method of  claim 12 , wherein the composition comprises a biocompatible, biodegradable and bioadhesive formulation. 
     
     
         19 . The method of  claim 12 , wherein the composition is suitable for administration from a pressurized metered dose inhaler device. 
     
     
         20 . The method of  claim 12 , wherein the composition further comprises ester mixtures or a mixture of saturated fatty acids.